Watch out EpiPen there’s (another) new kid on the block. On June 15, 2017, Adamis Pharmaceuticals received FDA approval for Symjepi, their new epinephrine injection. Symjepi joins Adrenaclick, Auvi-Q, and others as an alternative to the expensive treatment for severe allergic reactions. Adamis also anticipates a low cost for the life-saving medication.
As you may know Mylan Pharmaceuticals has been in the news quite a bit in the past year due to the price hike of their EpiPen and EpiPen Jr. products. The cost of EpiPen went up by close to 600%—an alarming price increase for a medication needed to prevent life-threatening allergic reactions.
The introduction of new epinephrine products, like Symjepi, as well as the reintroduction of Auvi-Q, the epinephrine injector that was recalled back in October 2015, should hopefully continue to drive the cost of these medications back down.
How will Symjepi be available?
How is Symjepi used?
Symjepi differs from EpiPen in that it’s a manual injection (not an auto-injector pen). You’ll inject the medication either intramuscularly (into the muscle) or subcutaneously (under the skin) into the outer thigh area. Symjepi can be injected through clothing if necessary.
A second dose of Symjepi may be necessary if symptoms continue or recur. If you need more than two injections though, be aware that only a healthcare provider should give additional doses of epinephrine.
Who can use Symjepi?
What are the side effects associated with Symjepi?
The most common side effects include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, nausea and vomiting, headache, and breathing problems. This is about the same for any epinephrine injection.
Is there anything unique about Symjepi?
Symjepi is expected to be low cost and have a small, user-friendly design. The manufacturer believes Symjepi could be an attractive option for a significant portion of both patients and professionals.
What other epinephrine products are out there?
- EpiPen and EpiPen Jr
- Epinephrine auto-injectors (generic alternatives for both EpiPen and Adrenaclick)
How much will Symjepi cost?
At this time the manufacturer has only said Symjepi will be “lower cost”—the exact price isn’t known yet.
When will Symjepi be available?
Is there a junior (lower dose) version of Symjepi?
No—currently, only the 0.3 mg/0.3 mL version is approved. However, according to the Adamis Pharmaceuticals press release, they are already preparing to submit the proper paperwork to the FDA to get approval for the junior (0.15 mg) version of Symjepi.
This update is the result of new data from the CANVAS and CANVAS-R clinical trials. This research showed that leg and foot amputations occurred two times more often in patients treated with canagliflozin than in patients who were given a placebo sugar pill. Amputations of the toe and foot were the most common; however, amputations involving the leg and knee also occurred.
Because of this finding, the FDA is now requiring manufacturers of these medications to add new warnings to drug labels, including a Black Boxed Warning.
What are these medications indicated for?
Invokana, Invokamet, and Invokamet XR are indicated, in addition to diet and exercise, for the treatment of type 2 diabetes. Doctors prescribe a canagliflozin-containing medication if the benefits of one of these medications outweigh any of their risks or serious side effects.
Before prescribing a canagliflozin-containing medication, your healthcare provider should consider your history of prior amputation, peripheral vascular disease, neuropathy and diabetic foot ulcers.
What signs and symptoms should a person prescribed a canagliflozin-containing medication look out for?
If you have been prescribed a canagliflozin-containing medication and think you are experiencing a severe side effect, some signs you should look out for include new pain or tenderness, sores or ulcers, or infections in your legs and feet.
Be sure to speak with your doctor if you experience any of these side effects. Do not stop taking any medication for your diabetes without talking to your healthcare provider. Doing so can lead to uncontrolled blood sugar levels that can be harmful. Over time, this can cause serious problems like blindness, nerve and kidney damage and heart disease
Are there any similar medications my doctor could switch me to?
At this time, only medications containing canagliflozin are of concern. The FDA has not issued any safety communications or warnings about other medications in the SGLT-2 inhibitor class.
Ventolin, Proair and Proventil are the albuterol inhalers commonly prescribed for people with asthma, reactive airway disease, or even for a persistent cough after an upper respiratory infection. Albuterol inhalers relax the muscles in the wall of the airways to improve wheezing and cough. Whether you’re prescribed a nebulizer or metered dose inhaler (MDI), albuterol is generally well tolerated—yet the same minor side effects are reported over and over again. So what can you expect to feel after using an albuterol inhaler?
- Tremor, especially of the hands, is the most frequent side effect occurring in 5% – 38% of people using these inhalers. Interestingly, the frequency increases with age. This will diminish quickly as your response to the drug peaks.
- Increased heart rate and palpitations may occur if you are using your inhaler frequently. The use of a spacer or chamber device reduces the chance of the “racing heart” side effect by reducing the amount of medication that deposits in your mouth. Xopenex (levalbuterol) is similar to albuterol but has less effect on your heart rate—so if you are experiencing heart symptoms from your albuterol inhaler let your doctor know. Be aware that Xopenex is slightly pricier.
- Dry mouth is another common symptom reported with the use of an albuterol inhaler. For short term relief of dry mouth, over the counter products like Biotene may help.
- Excitement is more common in children and adolescents 2 to 14 years, yet is still reported in as many as 1 in 5 adult albuterol users.
- Nervousness is reported in 4 – 15% of Ventolin, Proair, or Proventil users, but it should quickly resolve.
- Worsening asthma/bronchospasm. Wait, an inhaler designed to help your asthma may make symptoms worse? Yes, in 11 – 13% of folks, worsening symptoms of tight airways/asthma may occur. It’s called “paradoxical bronchoconstriction.” If you feel more wheezing, tightness, or shortness of breath after using albuterol, stop using it and speak to your doctor.
- Sore throat (pharyngitis). Pain and irritation of the throat is another symptom that as many as 14% of folks experience after the use of albuterol inhalers.
- Upper respiratory tract infection. This also seems odd, but up to 20% of adults using albuterol inhalers report upper respiratory tract infections as a result of their inhaler.
- Runny nose (rhinitis) is reported in 5 – 16% of those using albuterol inhalers.
- Nausea. More commonly reported in frequent albuterol inhaler users (with doses taken every 4 hours), the symptom of nausea occurs in 1 in 10 folks.
What have you noticed?
Manufacturer Bristol-Myers Squibb has issued a voluntary recall of Eliquis, a commonly prescribed blood thinner. Eliquis can be used to reduce the risk of stroke due to atrial fibrillation, treat blood clots, prevent future blood clots, and decrease the risk of blood clots following surgery.
This is a class 1 recall, the most serious type of recall, which means that there is a situation where there is a reasonable probability that use of the recalled medication may cause serious adverse health consequences or death. For more information on the different types of recalls, see our overview here.
Who can recall a drug?
A manufacturer can voluntarily recall their medication, or the Food and Drug Administration (FDA) can request or require that a manufacturer recalls a particular medication.
In this case, the Bristol-Myers Squibb has voluntarily recalled Eliquis, with the knowledge of the FDA.
Why has Eliquis been recalled?
Eliquis was recalled on June 10th, 2017, due to a possible packaging error. It was found that a bottle labeled as Eliquis 5 mg contained 2.5 mg tablets, a lower strength. Receiving the wrong strength of Eliquis could potentially cause severe adverse effects like a blood clot, stroke, or death.
At this time, there have not been any reports of injuries or illnesses related to this issue.
Which Eliquis packages were affected?
This recall applies to one lot and one NDC (package) shipped nationwide February 2017. This recall affects the following:
Manufacturer: Bristol-Myers Squibb
Lot: HN0063 (Expiration date: 9/2019)
National Drug Codes (NDCs): 00003-0894-2
What do I do if I think I have a recalled package of Eliquis?
If you think you have the recalled Eliquis product, contact your doctor and call the Bristol-Myers Squibb Customer Information Center at 1-800-332-2056, Monday – Friday, from 8am-8pm. You can also visit the Bristol-Myers Squibb website here for more information.
Always inspect your medications, including all parts of the packaging and devices. If you ever notice your medication doesn’t look or smell right, contact the manufacturer or ask your pharmacist for more information. You can also notify the FDA’s MedWatch Reporting Program as they can conduct further necessary investigations.
If you have diabetes, you’re probably no stranger to checking your own blood sugar with a little portable device known as a glucose meter. For those of you who don’t—to get a blood sugar reading, glucose meters require a small amount of blood to be placed on a test strip, and you need a new test strip every time.
Depending on your situation, your doctor might suggest checking your blood sugar multiple times per day with meals. Some of you may check your blood sugar upwards of 6 times a day. On the other hand, if you’re a newly diagnosed diabetic your doctor may not require you to check your blood sugar right away—though eventually you may need to test a few times per week.
No matter how often you check your blood sugar, the cost of test strips can add up quickly. Popular test strips can cost as much as (and sometimes more than) $1.50 each. That’s pretty steep if you’re testing a few times a day—almost $50 per month if you use one a day.
Especially if you need to test more often, you should be aware that there are a few meter systems that offer something like a subscription service. These companies offer unlimited test strips for a flat monthly fee.
There are several companies out there that offer unlimited test strips—here are just a few:
What is it? The Livongo program is available to individuals, their spouses, and dependents who are part of an organization that partners with Livongo. To register you must have type 1 or type 2 diabetes, have coverage, and a registration code. If you don’t have a registration code you are able to fill out a “Contact Us” form to learn more about their program.
How much does it cost? Livongo is free if you qualify through your employer, insurance, or other coverage. They don’t specify a certain quantity that you’ll receive at one time, but since the app monitors your use, they will ship you more supplies before you run out.
What features does it offer? You can get unlimited test strips and lancets delivered to your door. The Livongo mobile app also automatically uploads your blood sugar readings, and gives you access to view them online. It provides real-time tips based on your reading, and can notify someone you choose if your readings are outside your target range. You can also add info about what you’ve eaten to get a better understanding of your readings.
What is it? One Drop is a diabetes management platform. It lets you log your daily activities and see the relationships that food, insulin, and activity have to your glucose levels. You can download the app for free on iOS or Android, and they offer a paid monthly subscription for supplies.
How much does it cost? The One Drop meter costs $79.95. This is a one-time cost, and it includes the meter, lancets, a lancing device, a case, and test strips. Then, they offer monthly ($39.95) or annual ($399.95) subscriptions for unlimited test strip delivery—they’ll calculate how many test strips you’re using, and send you the amount you need. If you’re sure you want to commit, the yearly subscription will save you $79 per year—about the cost of the meter kit. The advantage of month-to-month is that you can cancel at any time.
What features does it offer? Along with the meter kit and test strips, you’ll have 24/7 access to talk to a Certified Diabetes Educator. The app can be used to track your blood sugar, reorder supplies, and let your doctor see your progress if you choose, so they can offer even more support. The app will also let you know when you’re running low on test strips, and how many you have left. There’s no extra cost based on how many test strips you use.
What is it? Offered by Roche, the manufacturer of Accu-Chek, this program offers a free meter for first time users and lets you subscribe to delivery one to six month supplies of test strips. Each package also comes with food and other “favorite” items suggested by Roche.
How much does it cost? You can choose whether to receive one or two boxes of 50 test strips in each shipment. A single 50-count box costs $30, and two boxes is $50. You can save a bit if you order more at a time—you also get to choose whether to receive your shipment will be delivered every one, two, three, or six months.
What features does it offer? In addition to test strips, you’ll get free “discovery” items that include snacks and skincare items, and free shipping. If it’s your first time using Accu-Chek, you’ll also get to choose a free meter. Billing is automatic, which can be an upside for convenience, but it’s something to be aware of if you just want to try the program out for a month or two.
What is it? Good Glucos is a customizable test strip subscription program. It comes with a meter, but doesn’t have an app like some other programs. One unique feature: Good Glucos gives away a 12-month subscription to someone in need for every 12 subscribers.
How much does it cost? Subscriptions start at 100 test strips per month for $35. However, you can customize your subscription by telling them how ofter you’re testing, and by setting your shipping frequency—but be aware that more strips will add to your cost. Shipping and your meter are free.
What features does it offer? Shipping is free, and your first package will come with 10 lancets as well as a free meter. Unlike some other services, they do not have an app to help you log and track your blood sugar, but if that isn’t important to you, this is one of the lower cost options. There’s no contract, so you can try the program for as long or as short as you’d like.
What is it? Like One Drop, Dario is a diabetes management platform. They offer an app in addition to the test strip subscription that can track your blood glucose, meals, and excercise, and offer insights, alerts, and reminders. The app is free, but it’s available for iOS only—there’s no Android option yet. If that works for you, the Dario meter plugs directly in to your phone for an easy connection with the app.
How much does it cost? The Dario smart meter costs $69.99, and comes with a disposable 25-test strip cartridge and lancing device. They do also offer lancets at $5.99 for 100. Test strip subscriptions are delivered every three months, and you can choose from quantities of 50 per month up to 300 strips per month. The cost starts at $49.50 for a three month supply, up to $225. You can also choose their “pay as you go” option instead of subscribing to get 50, 100, 200, or 300 test strips in a single shipment. 50 strips start at $20, up to 300 for $120.
What features does it offer? The meter connects directly to your phone through the headphone jack, and lets you use the app to read and track your blood glucose. You can also access all of your information through their web portal to make it easier to share with your doctor (or track yourself). Test strips come in 25-strip cartridges that you load into the meter for easy access.